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英語 から 中国語: FDA regulatory document General field: 医療 Detailed field: 法(一般)
原書のテキスト - 英語 Ports Covered by FDA
Most ports of entry into the U.S. are covered by FDA personnel, acting in cooperation with CBP. At these ports, where electronic entry submissions are filed, filers receiving a message indicating FDA review is required will provide appropriate additional entry information to the FDA office in whose territory the port of entry is located. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office. After the entry has been evaluated and a decision for additional documentation is made, FDA will take appropriate action. If FDA decides to collect a sample, it will provide the filer, importer, owner and/or consignee, where appropriate, with a Notice of Sampling and advise: (1) whether the entry is to be held intact for FDA examination or sampling; or, (2) specify only those items that need be held. Generally, when FDA wishes to sample, it will be acting upon its authority in the Customs regulations (19 CFR 151.4) to collect its own samples for examination.
翻訳 - 中国語 FDA 覆盖的口岸
多数进口口岸都配有与海关边防局(CBP) 合作的 FDA 人员。这些口岸的进口申请采用电子提交，如收到表明需要 FDA 审核的消息，申请者需向进口口岸所在辖区的 FDA 办公室额外提供适当的进口信息。对于提交纸质材料的进口申请，则需将所有适当的进口文件与申请文件包一起送至当地 FDA 办公室。对于经评估决定，需要额外文件的进口申请，FDA 将采取适当措施。如 FDA 决定采样，它将向适当的对象，即申请者、进口商、所有者和/或收货人，提供一份采样通知并向其咨询：(1) 进口产品是否将应 FDA 检查或采样而保持原封不动，或，(2) 仅说明需要保持的项目。通常情况下，在需要进行采样时，FDA 会根据海关条例 (19 CFR 151.4) 规定采集检查所用的样本。
原書のテキスト - 英語 1. How much warfarin to take each day
Your study doctor will explain to you the specifications and amounts of the warfarin pills to be taken each day. You must receive regular blood tests to evaluate your response to warfarin. This blood test is called an INR (International Normalized Ratio) test. The INR test evaluates how fast your blood clots. Your warfarin dosage will be adjusted accordingly.
When you first start taking warfarin, you need to have an INR test every XX-XX days until the INR value reaches or exceeds XX for XX consecutive days. Thereafter, you will need to have an INR test at least every XX weeks. Your study doctor may require you to have more INR tests, and your study doctor will tell you how to get an INR test. Your study doctor will examine the results of each INR test and adjust or maintain your warfarin dosage so that your INR is maintained within the target range of XX – XX.
Write down the dates of your INR tests and your new warfarin dosage in your diary.
翻訳 - 英語 Discussion: The major side effects of aminoglycoside drugs are renal toxicity, ototoxicity, neuromuscular blockagede and allergy. Amikacin has low toxicity among such drugs, where skin tests are not required for use. Currently, Amikacin was overly used by many clinicians in fundamental health institutes in China due to its features like low price, skin test-free, sensitivity of many bacteria to Kanamycin, and good efficacy. Cases with anaphylactic shock caused by intravenous infusion of amikacin has been reported. In this case, the Amikacin dose is relatively low, where erythema multiforme occurred in two intramuscular injections of amikacin, with the second severe than the first one on skin damage, which is much wider in range, and more difficult to treat. It is indicated that the skin rashes in the patient are caused by Amikacin. This case reminds us that children shall pay more attention on side effects of alleric reaction like skin rashes when administered with Amikacin.
英語 から 中国語: Camera Review General field: 技術/工学 Detailed field: エレクトロニクス/電子工学
原書のテキスト - 英語 Announced just eight months after the Panasonic Lumix DMC-GF2, the GF3 is as much about omission as addition. With the removal of the EVF port and hotshoe, the GF3 stands as the only G-series camera on which neither an electronic nor optical viewfinder can be used. Other prominent changes include the loss of the signature Panasonic rear click-dial and the camera body's sleeker, more rounded edges. These alterations give the GF3 an appearance more in line with that of a high-end compact camera than of its predecessor, the GF2.
Indeed, with the GF3, Panasonic offers a seamless upgrade path for compact camera users seeking higher image quality and more advanced shooting options. And perhaps for these users, the lack of a flash hotshoe and the downgrade from a stereo to mono microphone for video recording are sacrifices easily made in exchange for a smaller, lower-priced camera. In terms of features and performance, there is precious little in the GF3 that was not seen in either the GF2 or the more recently released Panasonic Lumix DMC-G3.
翻訳 - 英語 Furthermore, the Norovirus RNA level in the dust was 1.7×104~
1.6×105 copies_g, therefore, we think it is necessary to pay special attention on contaminated dust as one of the infection source. 8 of patient's stool samples were tested under real-time RT-PCR for the detection of Novovirus gene, where 7 samples were GII positive. Nobovirus belongs to Calicivirus, which is a kind of spherical virus with a diameter of 30~40 nm that has about 7,700 bases plus 1-stranded RNA genome.
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入会時期 Jan '12
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